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MGD009, a humanized DART® molecule that recognizes both B7-H3 and CD3 and has a prolonged serum half-life, is the second clinical program in our B7-H3 franchise. B7-H3 is a member of the B7 family of molecules involved in immune regulation, and is over-expressed on a wide variety of cancer cells, including cancer stem cells, as well as on the supporting tumor vasculature and underlying tissues, or stroma. Inhibition of certain members of the B7 family has been shown to have powerful anti-tumor effects in several solid tumor types. The primary mechanism of action of MGD009 is its ability to redirect T cells, via their CD3 component, to kill B7-H3-expressing cells.
In addition to MGD009, MacroGenics’ comprehensive B7-H3 franchise includes enoblituzumab, an Fc-optimized monoclonal antibody in Phase 1 clinical development, as well as MGC018, a pre-clinical antibody-drug conjugate (ADC) that also targets B7-H3. (Learn More – Enoblituzumab, MGC018)
A Phase 1 dose-escalation study of MGD009 is ongoing. This study is designed to characterize the safety and tolerability of MGD009 and establish the maximum tolerated dose (MTD) of MGD009 administered every two weeks among patients with non-small cell lung, bladder and head and neck cancer, mesothelioma, melanoma, and certain other B7-H3 positive tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD009 will also be assessed. MacroGenics expects to establish the monotherapy dose/schedule and initiate dose expansion cohorts in 2018. In addition, the Company anticipates the commencement of a combination study of MGD009 and MGA012 (anti-PD-1 mAb) in the first quarter of 2018.
MacroGenics retains full worldwide rights to the B7-H3 franchise (including MGD009).